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Global Drug Forecast and Market Analysis to 2022 REFERENCE CODE GDHC81PIDR | PUBLICATION DATE FEBRUARY 2014 SCHIZOPHRENIA – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary Schizophrenia: Key Metrics in the Seven Major The table above provides a summary of the key Pharmaceutical Markets, 2012–2022 metrics for schizophrenia in the seven major 2012 Epidemiology pharmaceutical markets during the forecast period Prevalent population 2.5 million from 2012–2022. Treated population 2.0 million 2012 Market Sales Schizophrenia Drug Sales by Region, 2012– US $5.2bn 2022 5EU $0.4bn Japan $0.7bn The combined sales of medications carrying an Total $6.3bn indication in schizophrenia were estimated at $6.3 Pipeline Assessment billion in 2012. By 2022, GlobalData projects these Number of drugs in Phase II–III 11 sales to grow to $7.9 billion, with a compound Number of first-in-class drugs 2 annual growth rate (CAGR) of 2.40% over the Peak-Year Promising Pipeline Candidates Sales course of the decade. These estimates cover the Brexpiprazole (Otsuka/Lundbeck) $1.8bn sales in the seven major markets (7MM) included Cariprazine (Forest/Gedeon Richter) $0.9bn in this report: the US, France, Germany, Italy, EVP-6124 (EnVivo/Mitsubishi Tanabe) $0.8bn Aripiprazole lauroxil (Alkermes) $0.7bn Spain, the UK, and Japan. We believe that the Invega Sustenna (Three-Month) $0.6bn following parameters will drive expansion in these Level of Key Events (2012–2022) markets: Impact Zyprexa (olanzapine) patent expiry in the ↓↓ Growing awareness of mental health 5EU in 2012 Seroquel (quetiapine) patent expiry in the US ↓↓ Enhanced community-level mental health care and 5EU in 2012 Geodon (ziprasidone) patent expiry in the US ↓ New product launches in 2012 Launch of Abilify Maintena (aripiprazole) in ↑↑↑ Increasing utilization of long-acting injectable the US in 2013 Abilify (aripiprazole) patent expiry in the US (LAI) antipsychotics ↓↓↓ and 5EU in 2015 2022 Market Sales US $6.1bn 5EU $0.4bn Japan $1.4bn 7MM $7.9bn Source: GlobalData. 7MM = US, France, Germany, Italy, Spain, UK, Japan; 5EU = France, Germany, Italy, Spain, UK Schizophrenia – Global Drug Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary The figure below illustrates schizophrenia drug Positive Symptom Therapies Dominate the sales in the 7MM by region during the forecast Schizophrenia Drug Market period. The pharmaceutical market for schizophrenia Schizophrenia Drug Sales by Region, 2012–2022 is composed solely of symptomatic therapies 2012 that confer significant improvements in positive 11% symptoms, but have little effect on negative 6% and cognitive symptoms of the disease. US Patients with schizophrenia have varying 5EU symptomatologies; negative-dominant Japan schizophrenia or cases with pronounced cognitive impairments are generally untreated by the current market options. In recognition of 83% the unmet therapeutic needs, current research 2022 and development (R&D) efforts are focused on 18% developing drugs with novel mechanisms that target negative and cognitive symptom 5% US clusters. Several key players in the industry 5EU Japan have concentrated on the two features of the disease that are currently without treatment 77% options: cognitive and negative symptoms. However, several of these novel mechanisms Source: GlobalData. in development are yet to be proven in clinical trials. Given the growing list of late-stage clinical trial failures, developing pharmacotherapies for negative and cognitive symptoms has proven to be challenging, but those agents that do emerge from the developmental landscape are poised to make a notable impact on the market and see substantial returns year-on-year. Schizophrenia - Global Drug Forecast and Market Analysis to 2022 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary The current schizophrenia drug The figure below provides an analysis of the armamentarium consists of first-generation and company portfolio gap in schizophrenia during the atypical antipsychotic medications. Due to the forecast period. high competition in the schizophrenia drug Company Portfolio Gap Analysis in Schizophrenia, market, new agents in the market have failed 2012–2022 to meet the needs of psychiatrists and their patients with schizophrenia. However, during the forecast period, the schizophrenia drug High market will encounter rapid changes as a result of patent expirations of key atypical products, Current Players and the companies that have led the market Current and Future Players Future Players will be challenged to maintain their positions. By now, physicians have an established Strength of Marketed Products Marketedof Strength Low familiarity with these courses of therapy. Product-line extensions have helped to increase brand awareness as well as offering Low High Strength of Pipeline different dosage forms that may help clinicians Source: GlobalData. achieve better treatment response. As LAIs are becoming increasingly utilized, product extensions, along with novel product launches, Unmet Needs are poised to emerge during the forecast The current schizophrenia market relies on period and become significant players in the first-generation antipsychotics (FGA) and schizophrenia drug market. atypical therapies that do not adequately Adjunct therapies are being pursued by several satisfy the needs of patients with the disease. companies. Add-on therapies may provide While these drugs can confer improvements in more complete symptomatic treatment by the patient’s positive symptoms like employing novel mechanisms. There is ample hallucinations and delusions, they do not space within the schizophrenia drug market for improve a patient with a flat emotional affect or therapies that can maintain efficacy more pronounced cognitive impairments, which can efficiently and with greater duration. disrupt a patient’s response to their treatment. The pipeline consists of several candidates that target negative and cognitive symptoms Schizophrenia - Global Drug Forecast and Market Analysis to 2022 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary and several new LAI therapies. Given the with a chronic antipsychotic treatment regimen. fierce competition in the indication, however, In addition, there are challenges in identifying they will have to demonstrate in clinical trials persistent negative and cognitive symptoms in and in practice that their utility surpasses those patients with schizophrenia. Supplementing of current market options. diagnosis with objective lab variables or biomarkers may help to identify treatment- An additional challenge facing schizophrenia is resistant, negative-predominant, cognitively the social stigma of mental health conditions in impaired, or suicidal patients, allowing for many areas of the world. The level of unmet treatments to be designed more specifically to need in schizophrenia and related mental meet their clinical needs. health disorders is one of the highest in medicine today, but the pharmaceutical Improving the ease-of-use, efficacy, and industry recognizes schizophrenia negative- duration of FGA and atypical therapies will symptom and cognitive-symptom therapeutics increase the quality of life (QOL) and treatment as “high-risk” investments. Consequently, response for patients with schizophrenia. government and academic institutions have However, oral administration of drugs can be stepped forward to become the key difficult in acutely exacerbated patients. contributors to R&D. Their contributions may Offering patients therapy in dosage forms that drive drug development by offering a better require less-frequent dosing or providing drugs understanding of the disease’s molecular with easier routes of administration can directly biology that provides the industry with novel affect their quality of care by improving targets for pharmacotherapy. medication compliance and relieving the demands on psychiatric healthcare services. Ample Market Opportunity The costs associated with novel LAI therapies As drug development shifts from dopamine are anticipated to be several-fold higher than and serotonin receptor blockade to new those of the current oral medications, several mechanisms of action, the need for curative of which are available as generics. Given that therapy will remain for patients with most patients with schizophrenia rely to some schizophrenia. However, it is not expected that extent on government-funded insurance a cure for schizophrenia will be developed by programs, it is especially important that cost- the current agents in the pipeline. minimization measures be implemented and Schizophrenia diagnosis remains a challenge, LAIs be prescribed appropriately to mitigate and first-episode psychosis is not usually met the costs associated with relapse. Schizophrenia - Global Drug Forecast and Market Analysis to 2022 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. SCHIZOPHRENIA - GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary The
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